Light and Sleep Fragmentation

NCT ID: NCT06009289

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2028-05-30

Brief Summary

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This trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.

Detailed Description

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Conditions

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Sleep Mild Cognitive Impairment Mood Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard of care

One hour of daily bright light exposure beginning one hour after wake time.

Group Type ACTIVE_COMPARATOR

Light therapy

Intervention Type BEHAVIORAL

One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor

Stepped care

One hour of daily bright light exposure in the afternoon

Group Type EXPERIMENTAL

Light therapy

Intervention Type BEHAVIORAL

One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor

Interventions

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Light therapy

One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Mild Cognitive Impairment
* Age \>65

Exclusion Criteria

* Severe depression
* Unstable psychiatric or medical disease
* Acute infection
Minimum Eligible Age

65 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jamie M. Zeitzer, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Redwood City, California, United States

Site Status

Countries

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United States

Central Contacts

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Renske Lok, PhD

Role: CONTACT

Facility Contacts

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Renske Lok, PhD

Role: primary

Other Identifiers

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IRB-71788

Identifier Type: -

Identifier Source: org_study_id

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